Medtronic has received U.S. Food and Drug Administration (FDA) approval for an expanded indication of its Evolut transcatheter aortic valve replacement (TAVR) systems. The new approval allows a Redo-TAVR procedure, in which a new Evolut transcatheter aortic valve (TAV) can be implanted inside any previously failed TAV.
The Redo-TAVR indication is designed for patients with failed valves — including severe aortic stenosis — who are considered high risk for open-heart surgery.
This milestone follows Medtronic’s May 2025 CE Mark approval for Redo-TAVR use in its Evolut Pro+, FX, and FX+ systems across Europe.
Dr. Michael Caskey, a cardiothoracic surgeon at Abrazo Arizona Heart Hospital, emphasized the significance of the decision, stating that FDA approval “empowers physicians to offer a critical treatment option for patients with failing TAVs who face high surgical risks” and provides future intervention options that could improve long-term outcomes and quality of life.
Alongside the approval, Medtronic has initiated the RESTORE study to evaluate Redo-TAVR outcomes in patients with symptomatic bioprosthetic valve failure. The trial will enroll 225 patients, with follow-up over 5 years. Primary endpoints include 30-day procedural success, 1-year freedom from mortality and stroke, as well as measures of safety, technical success, and quality of life.